期刊
LANCET
卷 379, 期 9825, 页码 1489-1497出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/S0140-6736(12)60204-9
关键词
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资金
- Novo Nordisk
- Novo Nordisk (Bagsvaerd, Denmark)
- Eli Lilly
- Sanofi
- University of Colorado for clinical research
- Merck
- Cebix
- MannKind
- Medtronic MiniMed
- DexCom
- Amylin Pharmaceutical
- Andromeda
- Bayhill Therapeutics
- Biodel
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Catabasis
- Diartis
- Elcelyx
- Exsulin
- GI Dynamics
- Halozyme
- Hoffman-La Roche
- Johnson and Johnson
- Lexicon
- LipoScience
- Metabolon
- Novan
- Novo Nordisk Pharmaceuticals
- Osiris Therapeutics
- Orexigen
- Pfizer
- Tolerex
- Transition Therapeutics
- TransPharma
- Amylin
- AstraZeneca
- Takeda
- Servier
- Merck Serono
- Dohme
- GlaxoSmithKline
- Merck Sharp
Background Intensive basal-bolus insulin therapy has been shown to improve glycaemic control and reduce the risk of long-term complications that are associated with type 1 diabetes mellitus. Insulin degludec is a new, ultra-longacting basal insulin. We therefore compared the efficacy and safety of insulin degludec and insulin glargine, both administered once daily with mealtime insulin aspart, in basal-bolus therapy for type 1 diabetes. Methods In an open-label, treat-to-target, non-inferiority trial, undertaken at 79 sites (hospitals and centres) in six countries, adults (aged >= 18 years) with type 1 diabetes (glycated haemoglobin [HbA(1c)] <= 10% [86 mmol/mol]), who had been treated with basal-bolus insulin for at least 1 year, were randomly assigned in a 3:1 ratio, with a computer-generated blocked allocation sequence, to insulin degludec or insulin glargine without stratification by use of a central interactive response system. The primary outcome was non-inferiority of degludec to glargine, assessed as a reduction in HbA(1c) after 52 weeks, with the intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT00982228. Findings Of 629 participants, 472 were randomly assigned to insulin degludec and 157 to insulin glargine; all were analysed in their respective treatment groups. At 1 year, HbA(1c) had fallen by 0.40% points (SE 0.03) and 0.39% points (0.07), respectively, with insulin degludec and insulin glargine (estimated treatment difference -0.01% points [95% CI -0.14 to 0.11]; p<0.0001 for non-inferiority testing) and 188 (40%) and 67 (43%) participants achieved a target HbA(1c) of less than 7% (<53 mmol/mol). Rates of overall confirmed hypoglycaemia (plasma glucose <3.1 mmol/L or severe) were similar in the insulin degludec and insulin glargine groups (42.54 vs 40.18 episodes per patient-year of exposure; estimated rate ratio [degludec to glargine] 1.07 [0.89 to 1.28]; p=0.48). The rate of nocturnal confirmed hypoglycaemia was 25% lower with degludec than with glargine (4.41 vs 5.86 episodes per patient-year of exposure; 0.75 [0.59 to 0.96]; p=0.021). Overall serious adverse event rates (14 vs 16 events per 100 patient-years of exposure) were similar for the insulin degludec and insulin glargine groups. Interpretation Insulin degludec might be a useful basal insulin for patients with type 1 diabetes because it provides effective glycaemic control while lowering the risk of nocturnal hypoglycaemia, which is a major limitation of insulin therapy.
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